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| Name of instrument/First year sold/Where designed | BIO-FLASH/2011/Spain |
| Country where manufactured/Where reagents manufactured | U.S./U.S. |
| No. of units in clinical use in U.S./Outside U.S. | 0/15 |
| Operational type/Model type/Sample handling system | continuous random access/benchtop/racks |
| Dimensions in inches (H × W × D)/Instrument footprint in sq. feet | 21 × 34 × 24/6 |
| Tests available on instrument in U.S. | tTG IgA, tTG IgG, aCL IgG, aCL IgM, DGP screen |
| Tests not available in U.S. but submitted for clearance | DGP IgA, DGP IgG, MPO, PR3, GBM, B2GP1 IgA, aCL IgA |
| Tests not available in U.S. but available in other countries | SS-B, Jo-1, Scl -70, Sm, RNP, Ro52, Ro60, ENA7, centromere |
| Tests in development | CCP3.1, ANA Screen, dsDNA, Ribo P, B2Gp1-Domain 1, DFS70 |
| Tests not available on other manufacturers’ analyzers | — |
| Fully automated microplate system | no |
| Number of each analyte performed in separate disposable unit | — |
| Number of wells in microplate | — |
| Methods supported/Separation methods | chemiluminescence/magnetic particle, bead |
| Number of different measured assays onboard simultaneously | 20 |
| Number of different assays programmed, calibrated at once | 50 |
| Number of user-definable (open) channels | 0 |
| Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set | 20/50 test kits |
| Shortest/Median onboard reagent stability/Refrigerated onboard | 480 hours/40 days/yes (6°–8°C) |
| Multiple reagent configurations supported | yes |
| Reagent container placed directly on system for use | yes |
| Reagents bar coded/Information in bar code | yes/type, No. of tests, lot number, expiration date, master calibration curve |
| Same capabilities when 3rd-party reagents used/Susceptibility to carryover | no/— |
| Walkaway capacity in minutes/Specimens/Tests-assays | —/30/20 |
| System is open (home-brew methods can be used)/Liquid or dry system | closed/liquid |
| Uses disposable cuvettes/Maximum number stored | yes/280 |
| Uses washable cuvettes/Replacement frequency | no/— |
| Minimum specimen volume required | 10 µL |
| Minimum sample vol. aspirated precisely at once/Minimum dead volume | 10 µL/50 µL |
| Supplied with UPS (backup power)/Requires floor drain | yes/no |
| Requires dedicated water system/Water consumption | no/— |
| Noise generated | — |
| Has dedicated pediatric sample cup/Dead volume | yes/50 µL |
| Primary tube sampling/Tube sizes/Pierces caps on primary tubes | yes/12–16 mm/no |
| Sample bar-code reading capability/Autodiscrimination | yes (2 of 5 interleaved, codes 39 and 128)/yes |
| Bar-code placement per CLSI standard Auto2A | yes |
| Onboard test auto inventory (determines volume in container) | yes |
| Measures No. of tests remaining/Short sample detection | yes/yes |
| Auto detection of adequate reagent or specimen | yes |
| Clot detection/Reflex testing capability | yes/yes |
| Hemolysis detection-quantitation/Turbidity detection-quantitation | no/no |
| Dilution of patient samples onboard/Automatic rerun capability | yes/yes |
| Sample volume can be increased to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results | no/yes |
| Time between initial result and reaspiration of sample for rerun | 30 minutes |
| Autocalibration or autocalibration alert | yes |
| Number of calibrators required for each analyte | 2 |
| Calibrants can be stored onboard/Average calibration frequency | no/lot change or failure of controls |
| Multipoint calib. supported/Multiple calibs. stored for same assay | yes/yes |
| How often QC required | daily |
| Onboard real-time QC/Support multiple QC lot Nos. per analyte | yes/yes |
| Automatic shutdown/Startup is programmable/Startup time | yes/yes/<10 minutes |
| Stat time to completion of β-hCG test | — |
| Time delay from ordering stat test to aspiration of sample | less than 5 minutes |
| Throughput per hour for three analytes on each specimen, in No. of specimens/No. of tests (cycle time) | 20/60 (30 minutes) |
| Can auto transfer QC results to LIS/Onboard capability to review QC | yes/yes |
| Data-management capability/Instrument vendor supplies LIS interface | onboard/yes, included |
| LIS interfaces up and running in active user sites | — |
| LIS interface operates simultaneously w/running assays | yes |
| Bidirectional interface capability | yes (broadcast download and host query) |
| Interface available (or will be) to auto specimen handling system | yes |
| Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component | yes/yes/no |
| Can order (via modem) malfunctioning part(s) w/o operator | no |
| On-site response time of service engineer | 24 hours |
| Mean time between failures/To repair failures | — |
| Avg. time to complete maintenance by lab personnel | weekly: 5 minutes; monthly: 15 minutes |
| Onboard maintenance records/Maintenance training demo module | no/no |
| List price/Targeted bed size or daily volume | —/100–500 |
| Annual service contract cost (24 hours/7 days) | — |
| Training provided w/purchase/Advanced operator training | —/yes |
| Distinguishing features (supplied by vendor) | random access, continuous load, chemiluminescent; benchtop footprint completing up to 450 results per shift; onboard reagents with stable calibration curves to eliminate batching and improve turnaround time |
| Tabulation does not represent an endorsement by the College of American Pathologists. |
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